Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Computer-Assisted Surgery
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- spatial coordinates of the target (3 translations and 3 rotations)
- Status
- Suspended
- Last Updated
- 17 years ago
Overview
Brief Summary
The main objective of this study is to validate a simplified platform of a repositioning system in orthognathic surgery (a third generation optic repositioning system called MicronTracker) compared with the actual clinically validated one (Orthopilot system).
Detailed Description
For the past 10 years, the use of computer-assisted surgery has expanded and is now widely spread in the orthopaedic domain, but not in maxillary-facial surgery. The main disadvantages of this technique are the necessity to fix a mark on the eyebrow with two transcutaneous pins, which is a long and invasive act, and to connect the infrared transmitter which is in contact with the patient with the computer in a limited surgery area. In this study, we want to show that the new repositioning optic systems are performing similarly to the actual validated one, that they permit to suppress the transcutaneous pins and the computer connection, and that it reduces the financial cost of this surgery. Neither the surgery technique, nor the pre-operative check-up will be modified in the study. The two repositioning systems will be used simultaneously during the mandibular osteotomy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Mandibular orthognathic surgery
Exclusion Criteria
- •Age \<18 years
Outcomes
Primary Outcomes
spatial coordinates of the target (3 translations and 3 rotations)
Time Frame: during surgery
Secondary Outcomes
- time to install the eyebrow mark with each technique.(during surgery)
- adverse events due to the transcutaneous pins.(during surgery)
- number of handling realized by the nurse for each technique.(during surgery)
- evaluation of cost: number of cable versus number of marker.(during surgery)